Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: 13vPnC; Biological: 20vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03828617

B7471008

Details and patient eligibility

About

This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.

Enrollment: 1,710 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female adults ≥18 and <50 years of age.
2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
3. Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.

Exclusion criteria

1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
2. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
3. History of microbiologically proven invasive disease caused by S pneumoniae.
4. Pregnant female subjects or breastfeeding female subjects (known or suspected).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,710 participants in 4 patient groups

20vPnC Lot 1

Experimental group

Description:

20vPnC Lot 1

Treatment:

Biological: 20vPnC

Biological: 20vPnC

Biological: 20vPnC

20vPnC Lot 2

Experimental group

Description:

20vPnC Lot 2

Treatment:

Biological: 20vPnC

Biological: 20vPnC

Biological: 20vPnC

20vPnC Lot 3

Experimental group

Description:

20vPnC Lot 3

Treatment:

Biological: 20vPnC

Biological: 20vPnC

Biological: 20vPnC

13vPnC

Active Comparator group

Description:

13vPnC

Treatment:

Biological: 13vPnC